Sotrovimab is being developed for the treatment of adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.

The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorization application. The EMA will assess the medicine's compliance with the usual standards for efficacy, safety, and quality.

An emergency use authorization application for sotrovimab has been submitted to the U.S. Food and Drug Administration. Sotrovimab is also under review by other global regulators, including Health Canada, under the expedited interim order application pathway for COVID-19 drugs.

EMA to review GSK, Vir COVID-19 mAb
GlaxoSmithKline (GSK) and Vir Biotechnology announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational...

GSK to provide services for Novavax's COVID-19 vaccine in the U.K.
GlaxoSmithKline (GSK) has signed an agreement in principle to support manufacturing of up to 60 million doses of Novavax's NVX-CoV2373 COVID-19 vaccine...

GSK, Vir file EUA submission for COVID-19 mAb treatment
GlaxoSmithKline (GSK) and Vir Biotechnology filed an emergency use authorization (EUA) application with the U.S. Food and Drug Administration for VIR-7831...

Medicago, GSK start phase III of COVID-19 vaccine trial
Medicago and GlaxoSmithKline (GSK) have started phase III of their adjuvanted COVID-19 vaccine candidate clinical trial.

Vir, GSK prepare to submit anti-COVID-19 mAb EUA
Vir Biotechnology and GlaxoSmithKline (GSK) are moving ahead with regulatory submission of their COVID-19 monoclonal antibody (mAb), VIR-7831, after a...